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New treatment option for The Number of Ventilator-free Days in the 28 Days Following LT
Official title Veno-arterial ExtraCorporeal Membrane Oxygenation to Reduce Morbidity and Mortality Following Lung TransPlant
ClinicalTrials.gov ID: NCT05664204
What this study is testing
- What it's testing
- In patients undergoing lung transplantation (LT), the investigators hypothesize that a "systematic" intraoperative ECMO strategy would reduce the need for invasive mechanical ventilation in the first 28 days without increasing adverse events, as compared to an "on-demand" intraoperative ECMO strategy. To date, LT remains a highly hazardous procedure.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Age \>18 years Assessed for bilateral sequential lung transplantation for obstructive or restrictive lung disease Affiliation to the French social...
You likely can't join if
- At listing :
- a pulmonary hypertension with a mPAP \> 45 mmHg, including in the absence of haemodynamic collapse (MAP, LVEF, RV function all normal)
- a pulmonary hypertension with echocardiographic evidences of right heart dysfunction (paradoxical septum or RV dilatation or RVEF \< 35%)
- a pre-capillary pulmonary hypertension at right heart catheterization with low cardiac output
- LT for primary pulmonary hypertension
- LT for cystic fibrosis and graft-vs-host disease
See the full eligibility criteria
- Age \>18 years Assessed for bilateral sequential lung transplantation for obstructive or restrictive lung disease Affiliation to the French social security Written informed consent
- At listing :
- a pulmonary hypertension with a mPAP \> 45 mmHg, including in the absence of haemodynamic collapse (MAP, LVEF, RV function all normal)
- a pulmonary hypertension with echocardiographic evidences of right heart dysfunction (paradoxical septum or RV dilatation or RVEF \< 35%)
- a pre-capillary pulmonary hypertension at right heart catheterization with low cardiac output
- LT for primary pulmonary hypertension
- LT for cystic fibrosis and graft-vs-host disease
- Re-do LT
- Combined multi-organ transplantation
- Active malignancy
- Pregnancy, breastfeeding
- Patients under guardianship (tutelle, curatelle, sauvegarde de justice) Socondary exclusion criteria: Patients without pulmonary hypertension or with pulmonary hypertension without right ventricular dilatation on an...
- preoperative severe pulmonary hypertension with hemodynamic collapse on echocardiography defined by: paradoxical septum or dilatation of the right ventricle or RVEF \< 20LT in a patient under ECMO as...
- PreLT hypoxemia with PaO2/FiO2 \< 80mmHg
- PreLT hypercapnia PaCO2 \> 80 mmHg after induction
The study team makes the final eligibility decision.
Where it's taking place
- Paris, France
- Suresnes, France
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Paris, France; Suresnes, France. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.